There are drugs out there that can lower costs, expand treatment options, and potentially save lives – but most of them cannot be accessed.
They are known as biosimilars and are drugs that do not differ significantly from biological drugs, also called reference products or biologics. These drugs come from living microorganisms, animal cells, or plants and are used to treat a variety of diseases, from breast cancer to autoimmune diseases. Although there may be subtle differences between biosimilars and their biological counterparts, studies have shown that these differences do not affect the drugs’ safety or effectiveness.
The biggest difference between biosimilars and reference drugs can be in their very different prices.
According to RAND Corporation, a public policy nonprofit, biosimilars could create competition in the pharmaceutical market by cutting spending by $ 54 billion by 2026.
HealthyWomen has played an active role in discussing how biosimilars affect women’s health. Last October, we brought experts together to discuss biosimilars in Washington, DC. And this November, at a public meeting of the Food and Drug Administration (FDA), I gave a talk on the re-authorization of the Biosimilar User Fee Act (BsUFA). First approved in 2017, the law allows the FDA to continue a program that provides resources to review new biosimilars and encourages the development of biosimilars that can provide safe, effective, and affordable treatments to the women who need them most.
The BsUFA will expire in September 2022 without renewed approval.
We can’t let that happen.
Women might be the biggest consumers of biosimilars … but they don’t know much about them
Europe pioneered the use of biosimilars in 2006 and slowly gained prominence in the US three years later in 2009. At this point, Congress created the Biologics Price Competition and Innovation Act (BPCI Act) to increase competition in the pharmaceutical market. Five years have passed since the FDA approved the first US biosimilar, Sandoz’s Zarxio, which reduces the risk of infection in patients receiving strong chemotherapy, which can cause low white blood cell counts.
Some of the diseases treated with biosimilars affect women disproportionately. For example, middle-aged women bear the greatest burden of chronic diseases like breast cancer and autoimmune diseases like rheumatoid arthritis, which can be treated with biosimilars.
Despite the potential women’s health benefits, a HealthyWomen survey in 2019 found that 70% of respondents did not understand biosimilars. This could be due in part to marketing tactics used by reference product manufacturers to keep cheaper biosimilars from coming to market – after all, lower costs could reduce their profits.
Many biosimilars fail to make it onto the pharmaceutical market
So far, the FDA has approved 28 biosimilars, but only a few are currently available on the market. And it’s more than a marketing tactic that keeps them from getting there. Although made to increase market competition and significantly lower the price of expensive biologics, some reference drug manufacturers have delayed their entry into the market by initiating litigation alleging biosimilars infringe patents protecting biologics .
To date, almost every biosimilar manufacturer is confronted or faced with such legal steps. This has a big impact on consumers who need options for cheaper drugs. For example, Hadlima, a biosimilar to Humira that treats arthritis, plaque psoriasis, and Crohn’s disease, cannot be sold in the US due to ongoing litigation and patent issues.
And even if biosimilars come onto the market because of the high process costs, the manufacturers of these drugs will not be able to reduce their costs as much as expected, which means that they have not yet achieved the goal of the BPCI law of increasing competition in the market and to lower prices significantly. Without increased competition, biologics and the few biosimilars that have hit the market will remain some of the most expensive drugs available, making them difficult for many women to afford.
One way forward
In 2018 the FDA published its Biosimilars Action Plan (BAP) for the purpose of “balancing innovation and competition”. BAP not only recognized the important role the FDA played in improving access to biosimilars, but also recognized obstacles to increasing the development and adoption of these drugs, including the need to raise public awareness.
In addition, the FDA has identified education as a necessary factor in the successful development and adoption of biosimilars and has done a fantastic job creating educational materials on these new drugs. However, for biosimilars to really gain a foothold in the pharmaceutical market, the FDA must continue to encourage increased patient outreach.
Our 2019 survey found that 65% of women would likely use affordable drugs if they had access to them. By building confidence in the cost and safety of biosimilars and their equivalence to biologics, consumers can begin to demand that more of these drugs come to market.
Women can take matters into their own hands by asking their healthcare providers for information about biosimilars, such as: For example, what they know about biosimilars, whether there is a biosimilar that can be used in place of the drug they are currently prescribed for their condition, and what their health care providers know about the research showing the safety and effectiveness of biosimilars.
It is important for the FDA to re-authorize the BsUFA. Not only will it provide resources for reviewing new biosimilars, but it will also enable the FDA to create accessible and understandable education campaigns to answer questions like these.
I suspect that the number of people who can receive biosimilars – especially women with chronic illnesses – would increase dramatically as more people learn how biosimilars can improve their lives.